Role and functions of the International Pharmacopoeia

Abstract

The role of a modern pharmacopoeia is to furnish quality specifications for drug substances and general requirements for dosage forms. The existence of such specifications and requirements is necessary for the proper functioning or regulatory control of drugs. Parmacopoeial requirements form a base for establishing quality requirements for individual pharmaceutical preparations in their final form. One hundred and forty independent countries are at present employing some 30 national and 3 regional pharmacopoeias. The aim of the international Pharmacopoeia issued by the World Health Organization as a recommendation, is to achieve a possibly wide global uniformity of quality specifications. The actual second edition of the International Pharmacopoeia was published in 1967 followed by a supplement in 1971. The Expert Committee on Specifications for Pharmaceutical Preparations, which is the body established by the World Health Organization to advise on quality specifications for drugs, during its 25th meeting, held in November 1974, recommended that the new edition of the International Pharmacopoeia should primarily include: -specifications for raw material comprising active and inactive ingredients used in pharmaceutical products; -general methods and tests necessary to support such specifications. Work on the new edition of the International Pharmacopoeia will comprise the revision of existing specifications and requirements, establishing specifications for new pharmaceutical substances, as well as establishing chemical reference substances, necessary to support such specifications. The actual procedure foresees appropriate consultations among the members of the WHO Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations. Extensive consultations with pharmacopoeia commissions are taking place to achieve a possibly high degree of unanimity on a global scale towards the quality requirements for pharmaceutical substances.